Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)

NACompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

February 8, 2018

Primary Completion Date

December 30, 2019

Study Completion Date

August 31, 2020

Conditions
Heart Failure
Interventions
DEVICE

echo-optimization

LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.

Trial Locations (1)

37126

Department of Cardiac Surgery, University of Verona, Verona

All Listed Sponsors
lead

Universita di Verona

OTHER

NCT03937570 - Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT) | Biotech Hunter | Biotech Hunter